Aortic Aneurysm, AbdominalPhase 2NCT06488898
Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
A Phase 2 study testing Allogeneic adipose tissue-derived mesenchymal stem cells in people with Aortic Aneurysm, Abdominal, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Phase IIa, single-center clinical trial compared with historical cohorts to evaluate the preliminary safety and efficacy of an allogeneic adipose tissue-derived mesenchymal stem cells infusion in an aneurysmal sac for the treatment of AAA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Allogeneic adipose tissue-derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jun 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.
- Subjects ≥ 18 years at the time of inclusion.
- Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched.
- Patients with an estimated life expectancy greater than 2 years at the time of inclusion.
- Women with childbearing capacity must have a negative pregnancy test at the time of inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their study participation.
- The patient must be able to attend all study visits and comply with all study procedures.
Who cannot join
- Patients with unresolved neoplasia history or hematologic disease.
- Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion.
- Patients with severe heart failure (New York Heart Association [NYHA] IV) or ejection fraction <20%.
- Patients with malignant ventricular arrhythmias
- Patients with deep vein thrombosis the last three months
- Patient with active sepsis at the time of inclusion
Show all 12Show fewer
- Patients with acute myocardial infarction or stroke in the previous month
- Any type of medical or psychiatric illness that, in investigator opinion, could be a reason for exclusion from the study.
- Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study.
- Administration of any investigational drug at the time of inclusion or in the 3 months prior
- Infants or pregnant women
- Transplanted patients.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Luis Riera del Moral, Doctor of Medicine, 917277000 ext. 441189, luis.riera@salud.madrid.org
About this study
Phase IIa, single-center clinical trial compared with historical cohorts to evaluate the preliminary safety and efficacy of an allogeneic adipose tissue-derived mesenchymal stem cells infusion in an aneurysmal sac for the treatment of AAA.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Allogeneic adipose tissue-derived mesenchymal stem cells
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adipose tissue-derived mesenchymal stem cellsDrug
Investigational medicinal product: Allogeneic adipose tissue-derived mesenchymal stem cells and expanded, which are considered an "advanced therapy medicinal product" under European regulation (Article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and the Council of November 13 th 2007 about advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004).
Administration form: Local injection by means of a catheter placed inside the previously excluded aneurysmal sac.
Administration dose: 1x10000000 cells/kg patient weight.
Administration guidelines: single infusion on the endovascular day AAA intervention.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic adipose tissue-derived mesenchymal stem cells | Experimental | Allogeneic adipose tissue-derived mesenchymal stem cells and expanded, which are considered an "advanced therapy medicinal product" according to European regulation (Regulation (EC) No 1394/2007). Receives: Drug: Allogeneic adipose tissue-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation of the study intervention:
The safety of the treatment will be evaluated using the following parameters:
- Proportion of procedure-related adverse events occurring throughout the study.
- Proportion of adverse events related to allogeneic mesenchymal stem cells infusión derived from adipose tissue occurred throughout the study.
- Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment.
Measured: 12 months
Secondary outcomes (1)
Efficacy evaluation of the study intervention.
Change in size of the aneurysm sac by using imaging tests performed during follow-up (CT and echo Doppler). A reduction of the aneurysm sac maximum diameter greater than or equal to 5mm in a period of 6 months is considered significant.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start13 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase IIa, single-center clinical trial compared with historical cohorts to evaluate the preliminary safety and efficacy of an allogeneic adipose tissue-derived mesenchymal stem cells infusion in an aneurysmal sac for the treatment of AAA.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo Dermatologico Y Estetico Pedro Jaen S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488898
- Sponsor's protocol ID
- HULP-STEM-EVAR-2020
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
- ClinicalTrials.gov ID
- NCT06488898
- Acronym / sponsor ID
- HULP-STEM-EVAR-2020
- Conditions
- Aortic Aneurysm, Abdominal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Grupo Dermatologico Y Estetico Pedro Jaen S.A.
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IIa, single-center clinical trial compared with historical cohorts to evaluate the preliminary safety and efficacy of an allogeneic adipose tissue-derived mesenchymal stem cells infusion in an aneurysmal sac for the treatment of AAA.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase IIa, single-center clinical trial compared with historical cohorts to evaluate the preliminary safety and efficacy of an allogeneic adipose tissue-derived mesenchymal stem cells infusion in an aneurysmal sac for the treatment of AAA.
| Arm | Type | Receives |
|---|---|---|
| Allogeneic adipose tissue-derived mesenchymal stem cells | Experimental | Drug: Allogeneic adipose tissue-derived mesenchymal stem cellsAllogeneic adipose tissue-derived mesenchymal stem cells and expanded, which are considered an "advanced therapy medicinal product" according to European regulation (Regulation (EC) No 1394/2007). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.
- Subjects ≥ 18 years at the time of inclusion.
- Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched.
- Patients with an estimated life expectancy greater than 2 years at the time of inclusion.
- Women with childbearing capacity must have a negative pregnancy test at the time of inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their study participation.
Key exclusion criteria (12 listed)
- Patients with unresolved neoplasia history or hematologic disease.
- Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion.
- Patients with severe heart failure (New York Heart Association [NYHA] IV) or ejection fraction <20%.
- Patients with malignant ventricular arrhythmias
- Patients with deep vein thrombosis the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic adipose tissue-derived mesenchymal stem cellsInvestigational medicinal product: Allogeneic adipose tissue-derived mesenchymal stem cells and expanded, which are considered an "advanced therapy medicinal product" under European regulation (Article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and the Council of November 13 th 2007 about advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004). Administration form: Local injection by means of a catheter placed inside the previously excluded aneurysmal sac. Administration dose: 1x10000000 cells/kg patient weight. Administration guidelines: single infusion on the endovascular day AAA intervention. | Drug | Allogeneic adipose tissue-derived mesenchymal stem cells |
Primary outcome
Safety evaluation of the study intervention:
Time frame: 12 months
The safety of the treatment will be evaluated using the following parameters: 1. Proportion of procedure-related adverse events occurring throughout the study. 2. Proportion of adverse events related to allogeneic mesenchymal stem cells infusión derived from adipose tissue occurred throughout the study. 3. Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment.
1 secondary outcome
Efficacy evaluation of the study intervention.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
Related trials for Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic adipose tissue-derived mesenchymal stem cells in people with Aortic Aneurysm, Abdominal, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation of the study intervention: (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.